AKL Research and Development Ltd. based at the Stevenage Bioscience Catalyst, in partnership with The University of Liverpool, has received clinical trial authorisation (CTA) to commence a phase I clinical trial to test AKL’s lead clinical candidate, APPA, as a potential new treatment for osteoarthritis. In addition, the trial has been approved for NIHR support.
Osteoarthritis (OA) is the most common type of arthritis in the UK, affecting more than eight million people, and is the leading cause of joint pain and stiffness in older people.
As part of the research and development programme, AKL,identifies promising phytochemicals with anti inflammatory properties which are capable of being synthesized.
In a variety of pre-clinical animal testing trials, APPA has clearly demonstrated significant pain relief from OA, improved functionality and the slowing of cartilage destruction. Having successfully passed preclinical toxicology studies, formal human studies are now about to start.
The clinical trial is being conducted at the Liverpoo lClinical Trials Unit (LCTU) led by rheumatologist Professor Robert Moots from the University’s Institute of Ageing and Chronic Disease.
Professor Moots, said: “The severe pain from OA is usually managed with prescription drugs that are often not effective and that also, in many cases, induce unacceptable side effects. In many cases, major joint replacement surgery is needed to help deal with the pain. This is surely wrong.
“This drug has huge potential to provide an effective treatment for OA. A reliable and easy way to treat OA has clear potential to save large amounts of money for the NHS and greatly improve the lifestyle and health of patients.
Research on how APPA affects human cells, especially activated neutrophils, is being led by Professor Steven Edwards at the University’s Institute of Integrative Biology.
Professor Edwards, said: There is now considerable evidence to show that neutrophils are activated in inflammatory diseases. They are however a “two-edged sword”: they are required to protect us from infections but their inappropriate activation can result in irreversible damage in inflammatory diseases.
“The ‘holy grail’ of anti-inflammatory targeting of neutrophils is specifically to block their tissue-damaging activities, but not compromise their ability to protect us. Work is ongoing but to date it appears that APPA does not target the host defence properties of neutrophils but does block their pro-inflammatory activities”.
DavidSharples, CEO, AKL, said: “Professor Moots is leading this important clinical trial and that, in conjunction with Professor Edwards’ research on APPA’s novel modes of action, should provide the robust evidence we need to help bring this drug to market. There remains a high unmet need for an effective, well tolerated OA drug, so understandably we are very excited by APPA’s prospects”.
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